Registration Dossier
Registration Dossier
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EC number: 700-990-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29/06/1981 - 08/09/1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study according to EPA Guideline (Fed. Reg. 43:163, 37336-37402, 1978), and is consistent with OECD Guideline 405, 1981. Performed under QA. Diet and environmental conditions not reported. Acceptable basic data.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guideline for registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals, Fed. Reg. 43:163, 37336-37402, 1978
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 9 rabbits; exposure time
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate
- EC Number:
- 700-990-0
- Cas Number:
- 68937-40-6
- Molecular formula:
- vary
- IUPAC Name:
- 4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report): tertbutylphenyl diphenyl phosphate
- Physical state: liquid
- Sample description: Butylated Arylphosphate - 10141D0404
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Stauffland albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California, USA
ENVIRONMENTAL CONDITIONS; No data
IN-LIFE DATES: No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%) - Duration of treatment / exposure:
- 3 rabbits: 20-30 seconds
6 rabbits: 7 days (unwashed) - Observation period (in vivo):
- 24, 48, and 72 hours, and at 4 and 7 days after treatment
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water in 3 rabbits (unwashed in the remaining 6 rabbits).
- Time after start of exposure: 20-30 seconds
SCORING SYSTEM: Numerical according to guidelines described by Draize (1965) (corneal, iridic and conjunctival irritation).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed and unwashed eyes
- Basis:
- mean
- Remarks:
- no irritation in any of the 6 animals tested
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- not measured
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- not measured
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- not measured
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- not measured
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- not measured
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- not measured
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Phosflex 72B produced no irritation in rabbits whose eyes were left unwashed or in rabbits whose eyes were washed 20-30 seconds after treatment.
- Other effects:
- None
Any other information on results incl. tables
Not relevant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Phosflex 72B was a non-irritant in the eyes of albino rabbits. This formulation produced no eye irritation in rabbits whose eyes were left unwashed or in rabbits whose eyes were washed 20-30 seconds after treatment. Based on the results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for eye irritation.
- Executive summary:
This eye irritation test, comparable to OECD Guideline 405, 1981, consists of a single instillation of 0.1.ml of the undiluted test material (Phosflex 72B) into one eye of each of 9 rabbits. The treated eye was washed with water 20-30 seconds after exposure in 3 rabbits and the eyes were left unwashed in the remaining 6 rabbits. The untreated eye of each animal served as a negative control. The cornea, the iris, and the bulbar and palpebral conjunctivae were observed at 24, 48, and 72 hours, and at 4 and 7 days after treatment. The guidelines described by Draize (1965) were used to assign numerical scores to the observed effects and to develop a weighted total score for each animal for each day of observations. Phosflex 72B produced no irritation in the washed and unwashed eyes of albino rabbits. Based on the results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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